Principal Clinical Trial Regulatory Affairs

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Collaborate as a Regulatory Subject Matter Expert with key functional area leaders on issues related to Site Activation pathways.

• Engage in strategic account and portfolio client meetings.

• Build and sustain strategic customer relationships while proactively assessing client needs.

• Ensure that project deliverables fulfill both internal and customer expectations, encompassing projections, reports, updates, and risk assessments.

• Establish execution strategies for milestones and key deliverables in coordination with project leadership.

• Prepare and present regulatory and submission strategies, along with status updates, during client meetings.

• Revise plans and compile controlled document requirements in alignment with SOPs and sponsor processes.

• Review core clinical trial study documents to ensure regulatory compliance.

• Coordinate and execute regulatory core submissions, including EU Clinical Trial Regulation Part I dossiers, while tracking submission packages.

• Examine regulatory considerations and Requests for Information from CTA Competent Authorities/Ethics Committees.

• Draft regulatory documents for submission as needed and agreed upon with the Sponsor.

• Prepare clinical trial application dossiers for amendments and modifications throughout the lifecycle of project maintenance.

• Conduct Regulatory Impact Assessments, identify potential gaps, and communicate risk mitigation strategies to Sponsors and project teams.

• Oversee the collection, quality review, and submission of applications specific to each country.

• Identify evidence gaps supporting submissions and contribute to regulatory recommendations and decisions.

• Review project budgets in relation to milestones while managing scope, profitability, and any out-of-scope work.

• Serve as a liaison between customer leaders and senior management regarding regulatory tasks and issues.

• Simplify complex technical regulatory issues into understandable language for non-technical audiences.

• Lead regulatory activities for projects with intricate regulatory profiles.

• Facilitate processes and communication within the CTRA team.

• Contribute to new business development, proposals, and strategic client initiatives.

• Assist management in project and departmental review meetings.

• Develop and deliver training programs and courses.

• Transfer knowledge to entry-level employees while providing technical expertise in multidisciplinary teams.

• Maintain adherence to quality standards, utilization targets, applicable regulations, and guidance documents.

⛳️ Requirements

• Bachelor’s Degree is required; a higher degree is preferred.

• Expertise in current regulatory frameworks, including regulations and guidelines for non-interventional studies, clinical trials, and medical devices.

• Experience adhering to applicable GxPs, including GVP, GCP, and ISO 14155.

• Comprehensive knowledge of clinical research management processes.

• In-depth understanding of pertinent regulations, drug development, and clinical project management procedures.

• Previous experience in budgeting and quality management.

• Ability to educate and mentor team members.

• Capacity to coach employees towards achieving performance objectives.

• Ability to identify and address unacceptable employee performance appropriately.

• Excellent written and verbal communication skills, along with strong interpersonal abilities to influence, convince, and persuade.

• Team-oriented mindset.

• Quality-focused approach to managed activities.

• Strong negotiation and problem-solving capabilities.

• Ability to provide constructive feedback and guidance to peers.

• Keep abreast of applicable regulations, laws, and guidance documents concerning pre- and/or post-market requirements for healthcare products.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive total rewards program.

• An inclusive culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Diverse career paths and employment opportunities.

• Collaboration within specialized therapeutic or functional teams.